Pennsaid
These highlights do not include all the information needed to use PENNSAID safely and effectively. See full prescribing information for PENNSAID. PENNSAID (diclofenac sodium) topical solution 2% w/w, for topical use Initial U.S. Approval: 1988
Approved
Approval ID
802cd382-443d-48e3-9c9d-fd946c73c79f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2022
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-040
Application NumberNDA204623
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 8, 2022
FDA Product Classification
INGREDIENTS (6)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 20 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT